Data Interpretation in Analgesic Clinical Trials With Statistically Nonsignificant Primary Analyses: An ACTTION Systematic Review

Gewandter, Jennifer S.; McKeown, Andrew; McDermott, Michael P.; Dworkin, Jordan D.; Smith, Shannon M.; Gross, Robert A.; Hunsinger, Matthew; Lin, Allison H.; Rappaport, Bob A.; Rice, Andrew S.C.; Rowbotham, Michael C.; Williams, Mark R.; Turk, Dennis C.; Dworkin, Robert H.

doi:10.1016/j.jpain.2014.10.003

Cited by 41 publications

(29 citation statements)

References 25 publications

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“…The authors refer to almost identical findings from general medical and pain literature suggesting that 'spin' is ingrained throughout the biomedical literature and that this is therefore not an isolated problem (7,10). Previous research has related reporting that is incompatible with results to commercial and industry funding (11); however, this was not reflected in the present analysis suggesting that other factors are at play.…”

supporting

confidence: 58%

Evidence of spin in clinical trials in the surgical literature

Fleming¹

2016

Ann. Transl. Med.

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supporting

confidence: 58%

Evidence of spin in clinical trials in the surgical literature

Fleming¹

2016

Ann. Transl. Med.

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“…Our study is the first to evaluate spin in otolaryngology journals, and our findings mirror the results of studies found in the general medicine literature. In the field of analgesics, a study found that spin was frequent in the abstracts of analgesic clinical trials, affecting 47% of results and 42% conclusion sections . Additional studies have found spin in obstetrics and gynecology journals and the psychiatry literature, and a particular study investigating high‐impact surgical journals found that the reporting and interpretation of results were frequently inconsistent with the raw data …”

Section: Discussionmentioning

confidence: 99%

Evaluation of spin in the abstracts of otolaryngology randomized controlled trials

et al. 2018

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Objective Spin, the misrepresentation and distortion of research findings, has been shown to affect clinical decision making. Spin has been found in randomized controlled trials (RCTs) published in various fields of medicine, but no study has tested for the presence of spin in otolaryngology RCTs. The purpose of this study is to evaluate the abstracts of RCTs found in the otolaryngology literature for spin. Methods In this cross‐sectional analysis, we analyzed the abstracts of RCTs for spin using a pilot‐tested form. Double data extraction was performed by two blinded authors, and discrepancies were resolved using mutual discussion. Results Out of the 534 PubMed citations retrieved by our search string, 162 parallel‐group RCTs with clearly defined primary and secondary endpoints were identified. Further analysis identified 47 trials with nonsignificant primary outcomes, which were then evaluated for spin. Spin was identified in 33 of the 47 (70%) abstracts. Spin was found in the results sections of 25 (53%) of the included abstracts and was found in the conclusion section of 27 (57%) of the abstracts. Spin was not present in the titles of any of the included studies. Conclusion Spin was common in our sample of otolaryngology RCTs. Spin may potentially create false impressions about the true validity of a drug or intervention. Further research needs to test for potential clinical implications of spin in the otolaryngology literature. Level of Evidence NA Laryngoscope, 129:2036–2040, 2019

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“…4 7 8 12–15 17 To further determine the extent to which concerns about drug efficacy are misrepresented in published papers, the method employed here can be applied to other fields. If misrepresentation of concerns proves to be widespread, a number of measures can be taken.…”

Section: Discussionmentioning

confidence: 99%

“…8 12–16 However, the fact that a primary outcome is positive does not preclude spin 11. Researchers might, for example, emphasise the most favourable-looking variable or manipulate figures 3…”

Section: Introductionmentioning

confidence: 99%

Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature

et al. 2017

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ObjectivesThis study aimed to determine the presence of spin in papers on positive randomised clinical trials (RCTs) of antidepressant medication for anxiety disorders by comparing concerns expressed in the Food and Drug Administration (FDA) reviews with those expressed in the published paper.MethodsFor every positive anxiety medication trial with a matching publication (n=41), two independent reviewers identified the concerns raised in the US FDA reviews and those in the published literature. Spin was identified when concerns or limitations were expressed by the FDA (about the efficacy of the study drug) but not in the corresponding published paper. Concerns mentioned in the papers but not by the FDA were scored as ‘non-FDA’ concerns.FindingsOnly six out of 35 (17%) of the FDA concerns pertaining to drug efficacy were reported in the papers. Two papers mentioned a concern that fit the FDA categories, but was not mentioned in the corresponding FDA review. Eighty-seven non-FDA concerns were counted, which often reflected general concerns or concerns related to the study design.ConclusionsResults indicate the presence of substantial spin in the clinical trial literature on drugs for anxiety disorders. In papers describing RCTs on anxiety medication, the concerns raised by the authors differed from those raised by the FDA. Published papers mentioned a large number of generic concerns about RCTs, such as a lack of long-term research and limited generalisability, while they mentioned few concerns about drug efficacy. These results warrant the promotion of independent statistical review, reporting of patient-level data, more study of spin, and an increased expectation that authors report FDA concerns.

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Data Interpretation in Analgesic Clinical Trials With Statistically Nonsignificant Primary Analyses: An ACTTION Systematic Review

Cited by 41 publications

References 25 publications

Evidence of spin in clinical trials in the surgical literature

Evidence of spin in clinical trials in the surgical literature

Evaluation of spin in the abstracts of otolaryngology randomized controlled trials

Spin in RCTs of anxiety medication with a positive primary outcome: a comparison of concerns expressed by the US FDA and in the published literature

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